By Fineline Cube 
French pharmaceutical giant Sanofi (NASDAQ: SNY) today announced that its investigational drug Tzield (teplizumab) has been approved by China’s National Medical Products Administration (NMPA) for use in pediatric and adult patients aged eight years and older who have Stage 2 Type 1 Diabetes. The approval enables clinicians to delay the progression of the disease to the more severe Stage 3 for up to three years.
How Tzield Works
Tzield is a CD3‑targeted monoclonal antibody that preserves the body’s own pancreatic islet function. By modulating the immune response, it allows the beta cells to continue insulin production longer, giving patients and clinicians a critical window to manage the disease before it advances to the insulin‑dependent Stage 3.
Regulatory Milestone
- Approval Scope – NMPA clearance for patients ≥ 8 years with Stage 2 Type 1 Diabetes.
- First Prescription – The drug was first prescribed in Asia at the Boao International Hospital in June, marking Sanofi’s initial commercial entry into the region.
- Strategic Impact – The approval positions Tzield as a frontline therapeutic option in China, potentially expanding Sanofi’s global pipeline in autoimmune diabetes treatments.
Market Implications
- Patient Benefit – The therapy offers a disease‑modifying approach, reducing the time to insulin dependence and improving quality of life.
- Commercial Opportunity – China’s large Type 1 Diabetes population and increasing demand for disease‑modifying therapies create a significant revenue potential for Sanofi.
- Competitive Landscape – Tzield’s unique mechanism complements existing insulin therapies and other immunomodulators, strengthening Sanofi’s portfolio against emerging competitors.-Fineline Info & Tech